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Impact of Transcatheter Aortic Valve Implantation (TAVI) on the Gut Microbiota in Patients With Aortic Valve Stenosis

Recruitingn/aAges any - anyAllHippocration General Hospital
NCT07052071 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study investigates the impact of transcatheter aortic valve implantation (TAVI) on the composition and function of the gut microbiota in patients with severe aortic valve stenosis. The improvement in haemodynamics following TAVI may positively influence gut microbial balance by increasing splanchnic perfusion and reducing intestinal congestion. A total of 40 patients undergoing TAVI at the "Hippokration" General Hospital of Athens will be enrolled, with the aim of analysing stool and blood samples before and after the procedure. The primary endpoint is the change in gut microbiota composition two months post-TAVI, assessed via 16S rRNA sequencing. Secondary endpoints include changes in serum TMAO levels and their association with the severity of aortic stenosis and post-procedural valve haemodynamics. Data will be collected at two timepoints (1 month up to 1 day pre-TAVI and 3 to 4

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📋 Eligibility rules (as published)
Inclusion Criteria: * Aortic stenosis suitable for TAVI Exclusion Criteria: Patients will be excluded if they present any condition or intervention that may independently affect gut microbiota composition. These include: * Use of antibiotics, systemic corticosteroids, antivirals, probiotics, bile acid sequestrants, or new medications within one month prior to enrollment. * History of inflammatory bowel disease. * End-stage renal disease requiring dialysis. * End-stage chronic liver disease. * Acute infection. Patients with aortic stenosis due to rheumatic fever or infectious endocarditis will be excluded. * Active cancer under treatment. * Psychiatric illness impairing ability to consent. * Substance or alcohol abuse.
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What it tests

  • TAVI
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Where

1 site
Hippokration General Hospital of Athens
Athens, Greece
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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